Application 077652
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LEVOFLOXACIN | LEVOFLOXACIN | TABLET;ORAL | 250MG | No | No |
| 002 | LEVOFLOXACIN | LEVOFLOXACIN | TABLET;ORAL | 500MG | No | No |
| 003 | LEVOFLOXACIN | LEVOFLOXACIN | TABLET;ORAL | 750MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 10544-451 | levofloxacin | levofloxacin | Blenheim Pharmacal, Inc. | ANDA | Current |
| 42708-063 | levofloxacin | levofloxacin | QPharma Inc | ANDA | Current |
| 50090-2540 | levofloxacin | levofloxacin | A-S Medication Solutions | ANDA | Current |
| 50090-2736 | levofloxacin | levofloxacin | A-S Medication Solutions | ANDA | Current |
| 58118-1016 | levofloxacin | levofloxacin | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-1016 | levofloxacin | levofloxacin | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 63187-514 | levofloxacin | levofloxacin | Proficient Rx LP | ANDA | Current |
| 63187-514 | levofloxacin | levofloxacin | Proficient Rx LP | ANDA | Current |
| 63187-514 | levofloxacin | levofloxacin | Proficient Rx LP | ANDA | Current |
| 63629-7050 | levofloxacin | levofloxacin | Bryant Ranch Prepack | ANDA | Current |
| 63629-7050 | levofloxacin | levofloxacin | Bryant Ranch Prepack | ANDA | Current |
| 65841-691 | levofloxacin | levofloxacin | Cadila Healthcare Limited | ANDA | Current |
| 65841-691 | levofloxacin | levofloxacin | Cadila Healthcare Limited | ANDA | Current |
| 65841-691 | levofloxacin | levofloxacin | Cadila Healthcare Limited | ANDA | Current |
| 65841-691 | levofloxacin | levofloxacin | Cadila Healthcare Limited | ANDA | Current |
| 65841-691 | levofloxacin | levofloxacin | Cadila Healthcare Limited | ANDA | Current |
| 65841-692 | levofloxacin | levofloxacin | Cadila Healthcare Limited | ANDA | Current |
| 65841-692 | levofloxacin | levofloxacin | Cadila Healthcare Limited | ANDA | Current |
| 65841-692 | levofloxacin | levofloxacin | Cadila Healthcare Limited | ANDA | Current |
| 65841-692 | levofloxacin | levofloxacin | Cadila Healthcare Limited | ANDA | Current |
| 65841-692 | levofloxacin | levofloxacin | Cadila Healthcare Limited | ANDA | Current |
| 65841-693 | levofloxacin | levofloxacin | Cadila Healthcare Limited | ANDA | Current |
| 65841-693 | levofloxacin | levofloxacin | Cadila Healthcare Limited | ANDA | Current |
| 65841-693 | levofloxacin | levofloxacin | Cadila Healthcare Limited | ANDA | Current |
| 65841-693 | levofloxacin | levofloxacin | Cadila Healthcare Limited | ANDA | Current |
| 65841-693 | levofloxacin | levofloxacin | Cadila Healthcare Limited | ANDA | Current |
| 67296-1119 | levofloxacin | levofloxacin | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1119 | levofloxacin | levofloxacin | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1123 | levofloxacin | levofloxacin | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1123 | levofloxacin | levofloxacin | RedPharm Drug, Inc. | ANDA | Current |
| 68382-015 | levofloxacin | levofloxacin | Zydus Pharmaceuticals (US | ANDA | Current |
| 68382-015 | levofloxacin | levofloxacin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-015 | levofloxacin | levofloxacin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-015 | levofloxacin | levofloxacin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-016 | levofloxacin | levofloxacin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-016 | levofloxacin | levofloxacin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-016 | levofloxacin | levofloxacin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-016 | levofloxacin | levofloxacin | Zydus Pharmaceuticals (US | ANDA | Current |
| 68382-017 | levofloxacin | levofloxacin | Zydus Pharmaceuticals (US | ANDA | Current |
| 68382-017 | levofloxacin | levofloxacin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-017 | levofloxacin | levofloxacin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-017 | levofloxacin | levofloxacin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 71335-0428 | levofloxacin | levofloxacin | Bryant Ranch Prepack | ANDA | Current |
| 71335-0428 | levofloxacin | levofloxacin | Bryant Ranch Prepack | ANDA | Current |
| 71335-0428 | levofloxacin | levofloxacin | Bryant Ranch Prepack | ANDA | Current |
| 72578-098 | levofloxacin | levofloxacin | Viona Pharmaceuticals Inc | ANDA | Current |
| 72578-098 | levofloxacin | levofloxacin | Viona Pharmaceuticals Inc | ANDA | Current |
| 72578-099 | levofloxacin | levofloxacin | Viona Pharmaceuticals Inc | ANDA | Current |
| 72578-099 | levofloxacin | levofloxacin | Viona Pharmaceuticals Inc | ANDA | Current |
| 72578-100 | levofloxacin | levofloxacin | Viona Pharmaceuticals Inc | ANDA | Current |
| 72578-100 | levofloxacin | levofloxacin | Viona Pharmaceuticals Inc | ANDA | Current |